Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2017-09-11
2018-10-24
Brief Summary
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Detailed Description
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During the 30 days before implantation the participant will be asked to take home a small computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be asked to use these items five (5) times a week for 30 minutes a session and interact with a displayed virtual reality environment. In this environment the participant will move their intact hand and the Leap Motion will display the hand movements in the virtual environment with the intact hand movements being mirrored between two hand facsimile. The participant will be instructed to move and stretch both their phantom and intact hand in a mirrored fashion. The purpose of these exercises are to allow the participant to become accustomed to the virtual reality setup (equipment and display) as well as providing a mirror box like effect where the virtual hand facsimile for their phantom hand is mapped to their body.
The second phase of the general design continues for 30-90 days post-implantation. We shall perform electrophysiological recordings from a single microelectrode array implanted into either the median, radial, or ulnar nerve. Neural signals (single and compound action potentials) evoked by variegated movements of the fingers and thumb will be recorded on the implanted microelectrode array. By recording electrical signals from the nerves the investigators hope to decode finger movements in real-time using machine learning algorithms. The participants will be asked to complete tasks in controlled virtual environment during the training phase. The virtual environment, which includes virtual arms and hands, will be presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task will require recording the position of arms in space which will be accomplished using the Vicon motion capture system that will use infra-red reflecting markers attached to the participant's arms. The investigators will also use a marker-less motion capture system, Leap Motion, to track the specific movements of the intact hand. Post training, the investigators aim to perform real-time decoding of finger movements in the virtual reality environments.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Transradial or Transhumeral amputees
High-count microelectrode arrays are implanted into the upper limb peripheral nerves of transradial or transhumeral amputees.
Microelectrode array
Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.
Interventions
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Microelectrode array
Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Incarceration
3. Inability to consent
4. Serious, untreated comorbidity
5. Patient is diagnosed with a medical condition(s) that seriously increase the risk of electrode implantation
18 Years
65 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
Arizona State University
OTHER
Mayo Clinic
OTHER
Responsible Party
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Shelley S. Noland
Principal Investigator
Principal Investigators
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Shelley Noland, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Arizona State University
Tempe, Arizona, United States
Countries
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Other Identifiers
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W81XWH-13-PRORP-TRA
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
14-007456
Identifier Type: -
Identifier Source: org_study_id